It is well known that there are literally tens of millions of patients throughout the world who suffer foot pain caused by cancer chemotherapy, plantar fasciitis or diabetic neuropathy. One serious side effect of such pain is that these patients do not have a normal walk, i. e., their gait is abnormal and not comfortable. Although there are many pain medications to reduce the level of pain experienced by such patients, these drugs often are not sufficiently palliative, and they typically can cause serious side effects.
One early invention to utilize magnetic fields to treat pain is described by Robert R. Holcomb in International Publication Number: WO 91/15263. The invention described in that document consists of four magnetic coils that are placed in the back of a chair or under a table where the patient's back would be exposed to the magnetic field. A DC current is placed through the four coils which results in an unchanging magnetic field to be experienced by the patient. Such a treatment with an unchanging magnetic field could have no therapeutic effect for any patient who would try to use such a treatment and is certainly not applicable for the treatment of foot pain.
In U.S. Pat. No. 6,402,678, Robert E. Fischell, et al describe a device to be placed on the head which can eliminate or reduce the pain of migraine headaches by the application of a series of intense magnetic pulses. This device was approved by the US FDA on May 22, 2014 and is currently in use to treat patients with migraine headaches. The Fischell, et al migraine treatment device operates by charging capacitors to a high voltage and then discharging them into a magnetic coil to create a magnetic pulse that reaches a peak intensity of about 0.8 Tesla in less than 200 microseconds. By Faraday's law, this changing magnetic field intensity creates an electrical pulse within the skull that has been shown to eliminate migraine headaches. Because it takes about 45 seconds to charge the condensers from a battery within this Transcranial Magnetic Stimulation (TMS) device, the rate of applying magnetic pulses to the brain is extremely slow; i. e., typically about one pulse per minute. Even at that, the time rate of change of the magnetic field within the brain and the neurons surrounding the brain results in an electrical current pulse in some neurons which can eliminate most migraine headaches. However, the application of more pulses per unit time and at a higher magnetic field intensity with a specially shaped magnetic coil does result in a more effective treatment for the relief of pain for other parts of the human body such as the feet for patients who suffer from foot pain caused by diabetic neuropathy or cancer chemotherapy.
An existing system that is currently available to treat lower back pain is called TENS which is an acronym for Transcutaneous Electrical Nerve Stimulator. This device has two adhesive covered electrodes that are pasted onto the patient's skin along the lower back or at several other possible locations. The device can then be turned on and the electrical intensity adjusted so that the pain in the skin is acceptable while some electrical pulses enter the body in the vicinity of the spine where they can provide some relief for lower back pain. However, it would be highly advantageous to use a system that could provide higher intensity electrical pulses much deeper into the body without causing any skin pain. That can be accomplished with TransCutaneous Magnetic Stimulation or TCMS as described herein.
One issued patent and three patent applications by Donald Burnett et al namely U.S. Pat. No. 6,701,185 (the '185 patent), and the patent publications US2003/0158585 (the '585 publication), US2004/0210254 (the '254 publication) and US2012/0302821 (the '821 publication). These inventions described in the Burnett et al patent and publications all have a consistent design for the use of magnetic pulsations for the treatment of pain, namely, comparatively small wire coils with all wires being in circular form and placed against the skin of the foot or wrapped around the knee or elbow with the use of comparatively low electrical currents. Specifically, this prior art has the following numbers of generally circular or curved magnetic coils: the '185 reference 6 coils; the '585 reference, 10 coils; the '254 reference, 9 coils; and the '821 reference, 30 coils. Not even one of these 49 coil designs has considered a single wire coil for the treatment of human pain. The Burnett et al references describe 23 different coil designs placed against the side of the foot and three different designs that are needles placed against the side of the foot. At no point in any of these prior art documents is there a single flat coil to be placed under the foot or on top of the foot for the treatment of foot pain.
In U.S. Pat. No. 9,550,067 (the '067 patent) and U.S. Pat. No. 9,849,302 (the '302 patent), Susan Fischell, et al describe in detail several types of foot coils for the treatment of foot pain. The '067 patent utilizes a single coil that is in the shape of a shoe. That design has several technical difficulties, namely: one size does not fit all foot pain patients. Therefore, many different sizes of magnetic coils would have to be made available for patients who have different sizes of their feet. It is also difficult for some patients to place his or her entire foot within this rigid structure of the foot-shaped magnetic coil and it takes more power to energize this coil shape because of its large size. The '302 patent utilizes three separate coils to cover the different regions of the foot. Each of the three coils is powered separately from a pulse generator and is used sequentially for the treatment of foot pain. An improved system as described herein would be able to use a single coil connected directly to a high current pulse generator to provide a sequential treatment for all surfaces of the foot and ankle from this single coil to eliminate or reduce foot pain.